Biodel to Report Results of VIAject Pivotal Phase III Clinical Trials at EASD Conference
DANBURY, Conn.--(BUSINESS WIRE)--Sep 3, 2008 - Biodel Inc. (Nasdaq: BIOD) announced today that it will report results of its two pivotal Phase III clinical trials of VIAject(TM) in patients with Type 1 and Type 2 diabetes next week at the 44th Annual Meeting of the European Association for the Study of Diabetes in Rome. Two posters summarizing these results, #677 by Flacke et al. entitled "Insulin VIAject(TM) and Regular Human Insulin in Patients with Type 1 Diabetes: Efficacy and Safety in an Open-Label Multicenter Clinical Trial", and #678 by Steiner et al. entitled "Insulin VIAject(TM) and Regular Human Insulin in Patients with Type 2 Diabetes: Efficacy and Safety in an Open-Label Multicenter Clinical Trial", will be presented at the conference during Poster Event C, PS 051 Hypoglycaemia which begins on Monday, September 8, 2008. The posters will be available for view at the EASD poster session hall and on the company's website at www.biodel.com beginning at 3:00 am Eastern Daylight Time (EDT)/9:00 am Central European Summer Time (CEST) on Monday, September 8, 2008. The authors will be present to discuss their work at their respective poster on Tuesday, September 9, 2008 from 12:30 pm to 1:30 pm CEST. Biodel will host a webcast and conference call on September 9, 2008 at 8:00 am EDT/2:00 pm CEST to present and discuss the data and answer questions about the findings.
Webcast/Conference Call Information
Biodel's senior management will host a webcast on Tuesday, September 9, 2008 at 8:00 am EDT/2:00 pm CEST during which they will present the data and discuss these results. Investors, members of the news media and the general public may access the Webcast presentation by logging on to the Investor section of Biodel's website at www.biodel.com. For those unable to access the Webcast, live audio of the conference call will be available by dialing 1-888-438-5493 (United States) or 1-719-325-2137 (international). An archived version of the Webcast will be available at Biodel's website.
VIAject(TM) is an ultra-rapid-acting injectable human insulin intended for meal-time use by patients with Type 1 or Type 2 diabetes. In Phase I and Phase II clinical trials, VIAject(TM) has been shown to have a more rapid onset of activity than those reported for the existing rapid-acting insulin analogs. VIAject(TM) has been tested in two pivotal Phase III clinical trials which compared the effects of VIAject(TM) to Humulin(R) R, the leading recombinant human insulin.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel's product candidates are developed by using VIAdel(TM) technology, which reformulates existing FDA-approved peptide drugs. The company's lead product candidate, VIAject(TM), is an ultra-rapid-acting injectable meal-time insulin in development for use by patients with Type 1 or Type 2 diabetes. VIAject(TM) has been tested in two pivotal Phase III clinical trials. Biodel's pipeline also includes VIAtab(TM) a sublingual tablet formulation of insulin in the Phase I stage of clinical testing, and two pre-clinical osteoporosis product candidates. For further information regarding Biodel, please visit the company's website at www.biodel.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, our ability to secure FDA approval for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel(TM) technology; the progress or success of our research, development and clinical programs, the initiation and completion of our clinical trials, the timing of the interim analyses and the timing or success of our product candidates, particularly VIAject(TM) and VIAtab(TM); our ability to secure additional patents for VIAject(TM) and our other product candidates; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2008. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
The Trout Group LLC
Seth Lewis, 617-583-1308
Posted: September 2008